Fluxergy has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company's high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).
The Fluxergy Analyzer system, which utilizes PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests performed by the company and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego (UC San Diego). The UC San Diego physician-scientist research team that conducted the validation, completed on March 27, 2020, has been led by Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health. Dr. Smith is a member of the Fluxergy Medical Advisory Board.
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Advanced rapid point-of-care PCR tests for COVID-19 like the Fluxergy Analyzer system may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy's on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.
"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally," said Dr. Ali Tinazli, Chief Commercial Officer at Fluxergy. "We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology."